Glycemic Control and Treatment Satisfaction Using Finesse Versus Pen for Initiating Bolus Insulin Dosing in Type 2 Diabetes Patients
Recruiting at51 trial locations
RM
Overseen byRichard M Bergenstal, MD
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Waitlist Available
Sponsor: Calibra Medical, Inc.
No Placebo Group
Trial Summary
What is the purpose of this trial?
To compare glycemic control and treatment satisfaction using a novel bolus insulin patch (Finesse) versus a pen for initiating and managing bolus insulin dosing in patients with T2DM not achieving glycemic targets on basal insulin with/without anti-hyperglycemic agents.
Research Team
RM
Richard M Bergenstal, MD
Principal Investigator
International Diabetes Center at Park Nicollet
Eligibility Criteria
Inclusion Criteria
Clinical diagnosis of T2DM
Treated with basal insulin for ≥ 6 months, with current dose stable for ≥ 6 weeks of ≥ 0.3 U/kg/day, with or without anti-hyperglycemic agents and in whom the Investigator feels advancement from basal to basal and bolus therapy is needed for the patient
A1C 7.5-11.0% by central lab value at screening visit
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Treatment Details
Interventions
- Bolus Insulin Patch (Calibra Finesse) (Insulin Delivery Device)
- Insulin Pen (Novo-Nordisk FlexPen®) (Insulin Delivery Device)
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: Bolus Insulin Patch (Calibra Finesse)Experimental Treatment1 Intervention
Use of the wearable patch to deliver meal-related bolus insulin dose
Group II: Insulin Pen (Novo-Nordisk FlexPen®)Active Control1 Intervention
Use of the pen device to deliver meal-related bolus insulin dose
Find a Clinic Near You
Who Is Running the Clinical Trial?
Calibra Medical, Inc.
Lead Sponsor
Trials
2
Recruited
320+
Medpace, Inc.
Industry Sponsor
Trials
98
Recruited
30,400+
Dr. August J. Troendle
Medpace, Inc.
Chief Executive Officer since 1992
MD from the University of Maryland, School of Medicine; MBA from Boston University
Dr. Reinilde Heyrman
Medpace, Inc.
Chief Medical Officer since 2017
MD